FDA.reportPublic FDA data

B4 Antiseptic Hand Sanitizer Gel

Manufacturer
Ming Fai Industrial (Shenzhen) Co. Ltd
Effective date
2019-11-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:55:01

Label at a glance#

ProductB4 Antiseptic Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • if condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylene glycol, caesalpinia spinosa gum, citric acid, ethylhexylglycerin, fragrance, glyceri, phenoxyethanol, sodium lauryl sulfate, water.

Packgae Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box2box2Inner Label2Inner Label2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56153-50156153-501-00, 56153-501-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
CAESALPINIA SPINOSA RESINWL3883U2POIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b814f1f2-c812-8aae-e053-2a95a90a6e3e4bbb5af2-8446-1988-e054-00144ff8d46c2021-01-04WarningsExact identifier
spl set id: 4bbb5af2-8446-1988-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.